Background: The success of fundoplication surgery varies widely; furthermore, complications after fundoplication can be common. We introduced a new device to treat GERD: biomechanical augmentation of the lower esophageal sphincter (LES) by use of a magnetic reinforcing appliance. Objectives: The aim was to determine whether a magnetic appliance could safely increase LES pressure, maintain a closed sphincter except during swallowing and belching, and increase the gastric yield pressure in a porcine model. Design: Ex vivo work-assessed design variables that would augment the reflux barrier yet still preserve swallow function. Porcine acute and chronic (44 weeks) postimplant studies were also performed. A single animal underwent planned device removal. Main Outcome Measurements: Gastric yield pressure, animal behavior, endoscopy, barium studies, balloon expansion studies, esophageal manometry, and histology. Results: Gastric yield pressure correlated with increasing magnetic forces (R2 = 0.5608, P < .001). The sphincter augmentation device was safe in all animals, with no observed effect on eating behavior and normal weight gain. The mucosa of the esophagus appeared normal at all intervals, and there was no device migration or significant tissue inflammation. The average LES pressure rose after implantation (P < .005). Balloon and barium studies demonstrated a closed sphincter with normal opening of the gastroesophageal junction during swallowing. Conclusions: Magnetic sphincter augmentation is a novel approach for the treatment of GERD. This study demonstrates the safety and feasibility of such a device in a porcine model. Further investigation of this device for the treatment of GERD in humans seems warranted.
ASJC Scopus subject areas
- Radiology Nuclear Medicine and imaging